PSCI 2270 - Week 12
Department of Political Science, Vanderbilt University
November 12, 2024
Ethical concerns in social sciences
The Common Rule and IRBs
Navigating institutional review
Risks of harm to human subjects:
Threats to privacy and confidentiality
Coercion threatens the autonomy of human subjects
Coercion in practice
Justice: Burdens of research fall disproportionately on some groups
Example: medical trials that rely on low income participants
Pursuit and communication of scientific knowledge
Disclosure of conflicts-of-interest
Code of Federal Regulations: The Common Rule
Creates Institutional Review Boards (IRBs; Human Subjects Committees) and specifies their jurisdiction and how they are to be constituted
Required of institutions that receive federal funding, and federal funding can be jeopardized by violations
Institutional review boards focus primarily on the well-being of human subjects
“Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes.”
“…the following activities are deemed not to be research: (1) Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.”
Human subject means a living individual about whom an investigator (whether professional or student) is conducting research:
Obtains information or biospecimens through intervention or interaction with the individual, and, uses, studies, or analyzes the information or biospecimens; or
Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
“Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.”
“When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.”
In order for an IRB to waive or alter consent… the IRB must find and document that:
The research involves no more than minimal risk to the subjects;
The research could not practicably be carried out without the requested waiver or alteration;
If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format;
The waiver or alteration will not adversely affect the rights and welfare of the subjects; and;
Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation.
Exempt research
Expedited review
If you would be reviewing ethics of the following projects, would you approve it as is, request a modification (what exactly?), or halt it?
(From APSA Guidelines) In general, when seeking consent, researchers should usually communicate:
Sometimes your research design requires to withhold crucial information from subjects during consent.
If your study has high academic/practical importance it can still be approved
Vandy is a bit complicated: Has two separate procedures for domestic and international projects
You are required to complete Human Subjects Training provided by CITI.